# K852025: Brandt Tracheal Tube (Tentative)

- Pathway: 510(k) (Traditional)
- Applicant: Mallinckrodt Critical Care
- Decided: Aug 13, 1985 after 97 days
- Product code: BTR (Tube, Tracheal (W/Wo Connector))
- Device class: 2
- Regulation: 21 CFR 868.5730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K050803: Pediatric Cuffed and Uncuffed ET Tubes; Standard Cuffed and Uncuffed ET Tubes (2005), 2 descendants of its own
- K113333: Kimberly-Clark  Kim Vent Microcuff Endotracheal Tube for Adults (2012), 0 descendants of its own
- K080821: Microcuff Pediatric Endotracheal Tube (2008), 0 descendants of its own

Source page: https://510kreport.com/device/K852025
Methodology: https://510kreport.com/methodology